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Anyone who knows this blogger is well aware this is a topic near and dear to her heart.  For years, plaintiffs railed against defendants making “boilerplate” objections to discovery requests.  So much so that the issue was addressed by the 2015 Amendments to the Federal Rules of Civil Procedure.  While Rule 33 for interrogatories already had a specificity requirement, Rule 34 was amended to require document request responses state “with specificity the grounds for objecting to the request, including the reasons” and each “objection must state whether any responsive materials are being withheld on the basis of that objection.”  But what about the opposite problem—requests that lack sufficient specificity. 

The Federal Rules have long required that discovery requests “describe with reasonable particularity” the information sought, and the 2015 Amendments added Rule 26(b)’s requirement that discovery be limited to information that is relevant and proportional to the needs of the case. In fact, Rule 26(g) requires counsel to certify that every discovery request is “neither unreasonable nor unduly burdensome or expensive, considering the needs of the case, prior discovery in the case, the amount in controversy, and the importance of the issues at stake in the action.”

Nevertheless, vague and overbroad discovery requests abound. The primary offender being requests for “any and all” documents or information. Plaintiffs believe they need such requests to reach the largest scope possible. In reality, all “any and all” requests end up doing is wasting everyone’s time resolving objections to narrow the scope to what is appropriate and proportional, likely through both meeting and conferring and motion practice. “Any and all” requests are particularly problematic in the context of ESI where a request for “all” documents could require the production of every identical copy located anywhere on a company’s servers. A reasonable basis for an objection.

Cases are fact specific and, therefore so should be discovery. For each discovery request, the plaintiff should be able to articulate how the information sought relates to an allegation in the complaint. If they can’t, then they aren’t doing their job. There is no requirement that plaintiffs serve all of their interrogatories and document requests at once.  That’s how we get into this mess in the first place.  Plaintiffs shoot off dozens of requests without stopping to think about what they really need and/or how to prioritize it. Some of the best and most productive discovery processes we’ve been involved with were when plaintiffs recognized that discovery is an iterative process and that discovery disputes are best negotiated in context. That is why staging discovery can be so important. Plaintiffs serve a few key requests that undisputedly seek relevant and proportional materials. They review the information and documents produced, get a basic understanding of the issues, engage in ongoing meet and confers to explore what else is needed, and if necessary, serve additional, “reasonably particular” requests based on their now informed position. We are not being Pollyanna-ish here. We know even an iterative process won’t be problem free. But specificity can sure smooth out a lot of bumps in the road.  

Now, if you look for case law on whether “any and all” discovery requests are acceptable or over broad, you will quickly discover that, as at Alice’s Restaurant, “you can get anything you want.” (We found this reference in Sullivan v. Glock, Inc., 175 F.R.D. 497, 505 (D. Md. 1997), and it was too good not to use). Afterall, courts are given broad discretion when it comes to determining the appropriate scope of discovery, which is driven by the facts of the case. But just like Arlo was singing his song “cause you may know somebody in a similar situation, or you may be in a similar situation, and if you’re in a situation like that,” we want you to know about In re: Exactech Polyethylene Orthopedic Products Liability Litigation, MDL 2044, 2024 U.S. Dist. LEXIS 184064 (E.D.N.Y. Oct. 3, 2024).

In the Exactech MDL, about 1800 plaintiffs allege that defendant’s polyethylene hip, knee, and ankle implants were manufactured and packaged in such a way that they were prone to premature wear that could lead to device failure, implant loosening, and pain.  Id. at *15-17. The court has entered numerous case management orders and substantial discovery was agreed to and produced. However, the parties were unable able to resolve their disputes in five categories.

First, plaintiffs sought to compel “all” communications or interactions between defendant and foreign government agencies and “all” investigations of defendant by foreign government agencies arguing that they went to defendant’s knowledge of the risks at issue.  Id. at *23-25. The court agreed that the requested information may be relevant to knowledge but found the demand for “all” such documents to be overly broad and unduly burdensome (burden outweighed likely benefit). Id. at *29.  Plaintiffs’ motion to compel was denied subject to them re-drafting the requests to make them “narrowly tailored.”  Id. 

Second, plaintiffs moved to compel defendant to produce “all” discovery produced in “similar” cases pending in state court. This is known as “cloned,” “copycat,” or “piggyback” discovery.  Defendant objected on the grounds that the other cases involve different facts, claims, and injuries.  Particularly, one case that plaintiffs sought the discovery from was an Anti-Kickback Statute and False Claims Act case. Again, the issue is not that some of the documents produced in those other cases may be relevant, they likely are. The issue is that a generic request for “all” discovery in another case is inherently non-specific and overbroad in violation of the Federal Rules.

Here, the court concluded that discovery in the non-products liability case was not discoverable because the claims were too dissimilar.  Id. at *32-33.  The court also denied the request for the discovery in the other products liability case because plaintiffs were not specific as to what documents from that production they were seeking and the court could not tell whether they would be relevant. Id. at *34.  The court was willing to entertain a revised request narrowly tailored to the products at issue in the MDL. 

Third, plaintiffs made three requests related to merger documents.  The first requested “all” due diligence documents.  Again, “all” was plaintiffs’ undoing. Their argument that the due diligence documents contain information about defendant’s contingent liabilities and knowledge of product defects only demonstrated that some of the documents might be relevant.  As written, the request was “overbroad and disproportional to the needs of the case,” and amounted to a fishing expedition through possibly millions of documents.  Id. at *36-37.  Plaintiffs’ motion was denied but they were permitted to submit a revised and narrowly tailored request.  Second, plaintiffs’ request for financial information contained in the merger documents was denied in its entirety as not seeking discoverable information.  Third, plaintiffs asked whether defendant disclosed “any issues” associated with its polyethylene products in the merger documents.  The court concluded that was a sufficiently narrow request to which defendant could answer yes or no but ordered no further document production until plaintiffs revised their requests.

Fourth, while defendant had agreed to produce twenty-seven custodial files, plaintiffs sought an additional six.  The court acknowledged that production of ESI presents “special challenges.”  As noted above, ESI is pervasive and therefore requests for “all” ESI are rarely proportional.  So, the party requesting additional custodians bears the burden of demonstrating that those custodians “would provide unique relevant information.”  Id. at *43. In other words, the new custodians cannot be duplicative of those already produced, such as requests for multiple people in the same department or who perform the same task.  Here, the court examined each of the six custodians and found (i) two files were inaccessible and not sufficiently relevant or unique to justify the expense of searching through backup files to reconstruct them;  (ii) another was sufficiently relevant, but plaintiffs will have to share in the costs of its production; (iii) two files that were available were sufficiently relevant and unique to require production, and (iv) the request for the last file was denied as cumulative.  Id. at *44-52.

Finally, defendants were using TAR (Technology Assisted Review or machine learning) to identify responsive documents for production. The parties had agreed on a TAR Protocol, except Plaintiffs wanted a provision that required Defendants to give them access to the non-privileged documents that were determined to be non-responsive.  Plaintiffs argued it was so plaintiffs could “explore” defendant’s responsiveness.  The court correctly recognized this as an attempt to conduct “discovery on discovery,” which is only allowed where the requesting party “provide[s] an adequate factual basis to justify the discovery” which can make an already expensive and time-consuming process even more so.  Plaintiffs had no such justification.  They pointed to no deficiency in defendant’s production or unreasonableness in the production process.  Id. at *54-55.  The protocol itself had sufficient transparency into the process defendant would use and defendant was well aware of its discovery obligations. 

Throughout this opinion, the court sends plaintiffs back to write a better question—one that is “narrowly tailored” to the facts of the case and the issues in dispute. This is not an unreasonable request. If plaintiffs focused more closely on specific facts rather than scorched earth, they could serve discovery that was efficient–less costly (for defendants), allowed for quicker responses (for plaintiffs), and decreased court involvement. A win-win-win situation. But for now, we are just like Arlo, “waitin’ for it to come around.”

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Our prior TwIqbal post concerning learned intermediary causation was well received by our readers, so we’re back with a second, related (and, as it turned out, even longer) discussion of pleading in prescription medical product warning litigation.

In addition to pleading causation, a product liability plaintiff alleging an inadequate warning must plead how the warning was inadequate.  Sounds rather obvious, but never underestimate the capacity of plaintiffs in our sandbox for failing to plead their cases.  The amount of precedent bouncing lazy plaintiffs for not bothering to allege what (they claim) is wrong with prescription medical product  warnings is surprisingly (or maybe not) extensive.

Continue Reading Using TwIqbal To Require Plaintiffs To Identify Claimed Warning Inadequacy
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Today we revisit the Lone Pine order for the Taxotere MDL.  We previously discussed the entry of the Lone Pine order and the court’s denial of plaintiffs’ motion to reconsider entry of the order.  Here, plaintiffs tried once again to take an axe to the Lone Pine, this time by arguing that it is unfair specifically with respect to deceased plaintiffs.  The court roundly rejected plaintiffs’ arguments. In re: Taxotere (Docetaxel) Prods. Liab. Litig., 2024 WL 4362982 (E.D. La. Oct. 1, 2024).

Continue Reading Taxotere Lone Pine Continues to Stand
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This is from the non-Dechert part of the Blog.

Over the years, the Blog has had many, many posts related to the issue of whether Pennsylvania recognized any form of strict liability in product liability actions against prescription medical products.  In addition to the fact that several of the principal authors of the Blog have been Pennsylvania lawyers, Pennsylvania has long been one of the focal points of litigation against the manufacturers of these products and some of the non-Pennsylvania lawyers among us have also spent plenty of time litigating product liability cases in Pennsylvania courts.  Even though the rejection of strict liability in favor of negligence has been clear for decades (see here for some history), plaintiffs have often tried to get courts to give them a path to recovery that did not require a showing of negligent conduct by the defendant.  Indeed, when courts created a novel cause of action on appeal in Lance, it was connected to the rejection of strict liability design defect and warnings theories (and the prescribing physician’s testimony negating proximate cause for failure to warn).  Yet, the appellate courts stood firm that Pennsylvania did not have strict liability for claims against prescription drugs.    

In the decade since Lance, we have covered a number of developments on this issue, including the issue of whether implantable medical devices would get the same treatment.  See here, here, and here, among many posts.  This included the Third Circuit referring the direct issue to the Pennsylvania Supreme Court in Ebert.  However, Ebert resolved before the Pennsylvania Supreme Court ruled, leaving the debate alive.  It was not much of a debate, as the vast majority of state and federal courts to consider the issue treated prescription implantable medical devices like prescription drugs and refused to extend strict liability to them.  The stubborn minority got started with a really bad decision from the Western District of Pennsylvania in a pelvic mesh case called Schrecengost, discussed here, which was followed in a handful of other pelvic and hernia mesh cases in federal courts over the next few years.  Why should cases involving surgical mesh, a prescription implantable medical device, get singled out for special treatment when it comes to Pennsylvania law?  There is no legal reason why they should.

Almost a year ago, in a hernia mesh case pending in the Middle District of Pennsylvania, the Magistrate Judge issued a report and recommendation that, among other things, predicted that the Pennsylvania Supreme Court would reject strict liability by applying comment k to implantable medical devices.  Douglas v. Atrium Med. Corp., No. 3:23-CV-0747, 2023 WL 8643638 (M.D. Pa. Dec. 11, 2023).  When that R&R identified contrary authority, it cited two surgical mesh decisions from Pennsylvania federal courts (one discussed here), each of which relied heavily on Schrecengost.  Despite its prediction that the strict liability claims were not viable, it noted what it thought was a still pending certified question in Ebert—the case had actually resolved much earlier, see Ebert v. C.R. Bard, Inc., 2021 WL 9950511 (3d Cir. Nov. 10, 2021)—and offered recommendations for outcomes other than dismissal with prejudice.

More recently, the district court ruled on the motions to dismiss that were the subject of the R&R.  Conveniently for us, the ruling on strict liability was the only one as to which a party had objected or not conceded the issue in briefing.  Douglas v. Atrium Med. Corp., No. 3:23-CV-0747, 2024 WL 4364950 (M.D. Pa. Sept. 20, 2024).  The district court rejected the plaintiffs’ objection on strict liability and adopted the R&R on this issue without much fanfare:  “The court agrees, and dismissal of Counts I and II is appropriate.”  Because other counts remained and recognizing that the Ebert certified question was never going to be answered, the court also considered plaintiffs’ request that it certify an interlocutory appeal to the Third Circuit to present the issue of strict liability for prescription implantable medical devices under Pennsylvania law.  (That would be the same Third Circuit that had certified a question to the Pennsylvania Supreme Court rather than make an Erie prediction on its own.)  Part of the test for certifying an interlocutory appeal under 28 U.S.C. § 1292(b) is whether there is “substantial ground for difference of opinion.”  The Douglas court found that there was not:

Here, the court finds that no substantial ground for difference of opinion as to whether plaintiffs’ strict liability claims should be dismissed.  As explained above, the appellate courts of Pennsylvania have ruled that the law supports dismissal.  Additionally, district courts within this judicial district have also rules that implanted medical devices are exempted from strict liability.

Id. at *4.

This all means that, despite some adverse decisions from federal courts in Pennsylvania, including in the same district as Douglas, the latest word on whether Pennsylvania law supports strict liability claims against an implantable medical device is that there is no substantial ground to conclude that it does.  We have been saying that for more than a decade, but it is nice to have a federal judge say that in late 2024.

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Long ago, a senior partner told us that clear writing flows from clear thinking. That might be so, but clear thinking and clear writing do not necessarily produce the correct result.  For example, you’d have a tough time finding a legal opinion written more clearly than Calchi v. Topco Assocs., LLC, 2024 U.S. Dist. LEXIS 177189 (N.D. Illinois Sept. 30, 2024). Indeed, the prose is delightful. But the outcome, at least for any card-carrying defense hack, is regrettable.

Judge Seeger is a much better writer than we are, so we’ll liberally borrow his words to describe what happened in the Calchi case. The plaintiff bought a bottle of over the counter (OTC) cold medicine.  “She wanted to feel better, but she didn’t want to feel drowsy. So she picked up a bottle” of cold medicine that claimed to be “non-drowsy.”  She took the medicine and became “unexpectedly drowsy.”  She concluded that the medicine “was to blame for her sudden urge to nap. She felt lousy, and then drowsy. And now, she feels duped.”   She filed a class action complaint alleging violations of consumer fraud statutes in 43 states plus the District of Columbia.  She also alleged breach of warranty under both state law and the Magnuson-Moss Warranty Act. Finally, there is a claim for intentional misrepresentation.

The defendant filed a motion to dismiss, arguing that the claims were preempted by federal law and that the plaintiff lacked standing.  There were other grounds as well, which we will get to soon enough.

Interestingly, the same plaintiff filed a virtually identical lawsuit in S.D.N.Y. against another non-drowsy cold medicine. That double-header prompted the Calchi court to entertain some skepticism, but not enough to affect the result.  The Calchi court also took note of the extraordinary proliferation of cases involving non-drowsy  medicine. “A lot of judicial energy is getting devoted to non-drowsy medication.”

The same plaintiff counsel authored many of the complaints. The complaints “read like fungible widgets” and it appears that plaintiff counsel “has fired up the litigation factory, and the machine spat out another complaint, courtesy of a few clicks and a well-oiled use of copy-and-paste.”  Moreover, the complaint is hardly specific to the plaintiff at all. “Most of the paragraphs could apply to any run-of-the-mill sick, drowsy plaintiff.”

How can such splendid phrase-making be in service of an opinion that is mostly pro-plaintiff?  Wait and see.

CAFA Jurisdiction

The Class Action Fairness Act (CAFA) applies to this case. That is important in Calchi, because the defendant was an LLC, which is treated as an unincorporated association under the statute.  Most of the time, the citizenship of an unincorporated association, as with a partnership, is the citizenship of all its members.  That rule would make diversity of citizenship difficult to establish. But CAFA provides that an unincorporated association, as with a corporation, is determined by principal place of business and place of organization. “The jurisdictional yardstick is different, depending on the type of case.  It might seem funny for a limited liability company to swap passports and have a different citizenship, depending on the nature of the case.  But Congress gets to set the rules.”

Therefore, CAFA supports federal diversity jurisdiction over the Calchi case.

Preemption

This is the part of the Calchi opinion that stings the most.  The label for the OTC medicine fully complied with the FDA monograph.  Federal law prohibits states from establishing any requirement for an OTC medicine that is “different from or in addition to, or that is otherwise not identical with,” the FDA requirements.  There is an out for personal injury cases, but that is not what we have in the Calchi case. The plaintiff merely wanted her money (and the money spent by all those class members) back.

Why isn’t this case preempted?  Even under the rotten Seventh Circuit Bausch case (the Calchi case – or perhaps we should say, this Calchi case – is in the N.D.Illinois, so it is controlled by Seventh Circuit law), this case seems to be a poster child for express preemption.

Sadly, there is another awful Seventh Circuit express preemption case: Bell v. Publix Super Markets, Inc., 982 F.3d 468 (7th Cir. 2020). Bell was about grated cheese. The package bragged that it contained “100% Grated Parmesan Cheese.”  According to the plaintiff, that “100%” was a lie, because there was also cellulose powder and potassium sorbate in the product.  The Bell court rejected the defendant’s preemption argument, drawing a distinction between requiring a defendant to make additional affirmative disclosures (preempted) versus stopping the defendant from voluntarily adding deceptive language to the federally permitted labels (not preempted).

In Calchi, the FDA did not require a drowsiness warning, so the plaintiff could not sue the defendant for not including a drowsiness warning.  But the defendant went off on its own and added the “non-drowsy” claim. The Calchi court “takes its marching orders from the Seventh Circuit. And the Seventh Circuit has ruled that ‘while states may not require sellers to add further labeling that is not required by federal law, they may prevent sellers from voluntarily adding deceptive content that is not required by federal law.”

That is bad enough. But the Calchi court also construed “misbranding” to be parallel to anything plaintiffs say is false. That reasoning makes express preemption more challenging than it should be.

The defendant’s dream of preemption might have died a hard death in Calchi, but die it most certainly did.

Standing

The defendant argued that the plaintiff had no standing to assert claims on behalf of class members under the laws of other states.  She bought the cold medicine in New York, not the other 43 jurisdictions.

The Calchi court held that the plaintiff had asserted an economic injury: “[s]he parted with money in her back pocket, and the money would still be there but for the misrepresentation.”  The court believed that the price-premium theory was “a bit shakier” but the plaintiff had enough “standing to get her foot in the door.”

But the court kicked the class representation issue down the road.  Whether the plaintiff can “represent drowsy people in other states is a question for another day.”

New York Consumer Protection Claim

The defendant argued that the plaintiff had inadequately alleged that the medicine induced drowsiness. The court deemed this argument as “a tough hill to climb at the motion-to-dismiss stage.”  The plaintiff alluded to adverse events and a scientific study conducted by a company that competed with the defendant.  The court held that such support, at least for now, was good enough.

The defendant also argued that no reasonable consumer would be hoodwinked by the non-drowsiness claim.  The court saw this argument as “a big ask.  Too big. Not everyone wants to feel sleepy after taking cold medicine.  Drivers don’t. Neither do people who want to feel better while pushing through the workday.”

The defendant sought to avail itself of New York’s safe harbor provision for products that comply with federal regulations. But the Calchi court held that the safe harbor provision was neutered by the same broad construction of “misbranded” that held off preemption.

Breach of Warranty

The defendant fared considerably better on the New York and Magnuson-Moss warranty claims.  Both statutes require plaintiffs to furnish reasonable pre-complaint notice to the defendant.  Here, the plaintiff waited six months to raise a beef with the defendant.  The court held that waiting six months is not “reasonable” and that the plaintiff “overslept on her rights.”  (At last the drowsy/sleep jokes cut in favor of the defendant on an issue.)

Intentional Misrepresentation and Rule 9(b)

Despite taking the plaintiff to task early in the opinion about the minimal factual content in this cookie-cutter complaint, when it gets to the fraud claim the Calchi court held that the particularity requirement of Fed. R. Civ. P. 9(b) was nonetheless satisfied.  That is not clever or funny; it is bizarre.

Injunctive Relief

The plaintiff in Calchi asked for “a slew of backward-looking remedies.”   She also asked for injunctive relief going forward to halt the “deceptive conduct.”  But the plaintiff did not allege that she will be purchasing the cold medicine again. Her whole point was that once the veil had been lifted from her eyes, she would not purchase the medicine.  The non-drowsy label “can’t trick her now.”  There is no danger of “fool me twice, so there is no basis for an injunction.”

But what of the other class members, you ask?  Standing is “not dispensed in gross.”  The named plaintiff has no standing to seek an injunction, so that relief is excised from the complaint.

That being said, the court gave the plaintiff the opportunity to amend the complaint and try to “plead facts sufficient to show standing for injunctive relief.”

Perhaps there will be another opinion in this case.  We fervently hope that the court’s admirable literary skills will be used to escort this zombie, sleepwalking case off the docket.

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So learned plaintiff in United States ex rel. Plaintiff v. Novo Nordisk, Inc., 2024 U.S. Dist. LEXIS 174825 (W.D. Wash. Sept. 26, 2024), when the court granted defendant’s two motions to compel obviously relevant documents and information.

Plaintiff relator and intervening plaintiff, the State of Washington, assert False Claims Act (“FCA”) claims against the manufacturer of a hemophilia drug alleging defendant promoted the drug off-label for prophylaxis and in high doses leading to the submission of non-reimbursable claims.  Id. at *3.   Before we get to the discovery requests at issue, the merits of this action are even more questionable than the other off-label FCA claims.  The FCA penalizes anyone who presents, or causes to be presented, to the federal government “a false or fraudulent claim for payment or approval.”  31 U.S.C. § 3729(a)(1).  So, there must be a “false claim.”  But where is the falsity in the case of truthful off-label promotion?  It doesn’t exist.  In this case, the off-label use at issue was in fact later approved by the FDA for marketing.  So, we ask again, where is the false claim if—medically—the use was safe, effective, and necessary. 

Since, however, the case is moving forward in discovery, at a minimum that discovery needs to be reciprocal.  It is not uncommon for state plaintiffs to dish it out, but try not to have to take it—discovery that is. 

Besides defendant’s drug, there was one available alternative therapy that for years was likewise prescribed off-label for prophylaxis and in high doses.  Defendant requested claims data from the state showing how it reimbursed prophylaxis or high dose claims of the alternative drug.  Information about how and why the state reimbursed these claims was directly relevant, particularly to materiality.  The state’s “assertion that similar reimbursements for similar off-label [drug] use  . . . are irrelevant is difficult to follow, and it is not persuasive.”  Id. at*8.  This information goes directly to the state’s “decision-making” and bears on causation, materiality, and damages. 

Having lost its relevance argument, plaintiff attempts to claim undue burden beyond what is proportional to the needs of the case.  First, plaintiff waived that argument by not making a burden objection in its discovery responses.  Second, plaintiff alleges tens of millions of dollars in damages, so discovery of the state’s historical reimbursement practices was neither disproportionate nor overly burdensome.  Id. at *9. 

Defendant’s second discovery request was for documents created by since-retired state employees that include “developing coverage policies and determining whether the drugs were medically necessary.”  Id. at *9-10.  Those documents specifically included data concerning claims made for defendant’s drug and records of consultations with clinicians about use of the drug.  Plaintiff did not dispute that these records are relevant and discoverable, but had “not even bothered to try to find” them.  Id. at *10.  The court rejected plaintiff’s procedural objection to defendant’s motion to compel and ordered the documents produced. 

State plaintiffs often fail to meet their discovery obligations in similar situations, so this is valuable precedent that governmental plaintiffs have to comply with discovery like all other parties. 

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It could be a first-year civil procedure question:  The removability of a case to federal court is determined as of the moment of removal – nothing thereafter can defeat removal.  See, e.g., St. Paul Mercury Indemnity. Co. v. Red Cab Co., 303 U.S. 283, 292 (1938) (a plaintiff cannot “deprive the district court of jurisdiction” “after removal” “by amendment of his pleadings”); 14A C. Wright & A. Miller, Federal Practice & Procedure §3721, at 213 (2d ed. 1985) (once “a case has been properly removed . . . plaintiff[s] cannot successfully do anything to defeat federal jurisdiction and force a remand”).

That is precisely what the petitioner in a pending United States Supreme Court matter, Royal Canin U.S.A., Inc. v. Wullschleger, No. 23-677, is asking the Court to hold.  Oral argument in the Royal Canin case is occurring today.  For more details, including copies of all pleadings, see the SCOTUSblog page.

Continue Reading Under the Radar SCOTUS Removal Issue
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We receive emails from readers fairly regularly.  They are usually from other attorneys, sometimes friends or acquaintances sharing their points of view or expanding on things that we may have underplayed or overlooked.  Although we don’t spend much time (or really any time) trying to predict when we might hear from others, we have noticed a trend.  We are far more likely to hear from readers when we write on (1) vaccines and (2) particular geographic locations.  Anti-vaxxers have strong opinions, and they relish opportunities to express them, including in sometimes-not-very-nice emails to defense-hack bloggers.  To that, we can attest. 

With regard to particular geographic locations, readers seem to relate to stories more when they have familiar settings.  We recently wrote on a case from Montana, and while no one wrote to comment on the substance of the post, we received numerous emails informing us that Yellowstone National Park is mostly in Wyoming and that Joe Montana is, in fact, from Pennsylvania.  We have received multiple “I’m from [fill in the state here]” emails over the years, uniformly stated with a sense of community and with none of the vitriol that vaccine posts tend to provoke.

All this came to mind today because we were reading an interesting case from Kentucky.  We thought at first that we have never been to Kentucky.  Then we looked at a map.  There was that one time we drove from Florida to Chicago at the end of Spring Break in law school, and based on compelling cartographic evidence, we must have travelled through Kentucky.  Our lack of memory is our loss.  The Bluegrass State is famous for its natural beauty, and it is the birthplace of two of the most famous individuals in history—Abraham Lincoln and Muhammed Ali.  We might someday attend the Kentucky Derby, but probably not.  And, we can’t help but recall the old joke, “Is the capital of Kentucky pronounced Looee-ville or Lewis-ville?”  The correct answer is that the capital of Kentucky is pronounced “Frankfort.” 

This is a long warm up to the aforementioned interesting case from Kentucky, Cordle v. Enovis Corp., Civil Case No. 23-93, 2024 U.S. Dist. LEXIS 170100 (E.D. Ky. Sept. 20, 2024), where the district court dismissed the plaintiff’s complaint because she leveled allegations against the “defendants” collectively, without specifying which one allegedly caused her injury.  This is a twist on TwIqbal that we have not often seen.  (You can see our TwIqbal cheat sheet here.)  The plaintiff alleged that she was injured by a protective knee brace, but she alleged only that the brace “was designed, manufactured, assembled, distributed, and provided to . . . [her] by . . . Defendants.”  Id. at *10 (emphasis added). 

She did not specific which defendant (there were at least four).  That was a problem.  The Kentucky Product Liability Act requires proof of causation, i.e., that the defendant’s product is responsible for the alleged injury.  Under this rule, “[w]here a complaint names multiple defendants where only one could be responsible it ‘allows the court to infer only a mere possibility’ that a particular defendant caused the harm.”  Id. at *9. 

Here, the plaintiff provided “no information whatsoever” about what any particular defendant did or did not do.  Citing Twombly, the district court found this to be a fundamental pleadings failure because it failed to allege anything more than a mere possibility that each of the defendants caused the plaintiff’s injury.  Id. at *12-*13.  A mere possibility of causation is not sufficient.  Moreover, although this is a rare application of TwIqbal, we don’t see why it would not apply in other jurisdictions.  The district court tied the plaintiff’s burden to the Kentucky Product Liability Act, but that statute is not unique on causation.  Every state requires proof of causation in product liability actions, particularly those sounding in tort. 

There was another problem with this plaintiff’s pleadings.  The plaintiff dutifully alleged that her brace broke and malfunctioned and that it was “unreasonably dangerous” and defective in design and manufacturing.  She did not, however, allege how the device was defective.  Id. at *17-*18.  She alleged that she was using the device properly when it malfunctioned and bent.  But merely parroting the word “defective” does not state a claim, and this is just one of multiple cases holding that a device is not defective just because it failed.  All medical devices have risks. 

The plaintiff therefore alleged neither a product defect nor causation, which led the district court to dismiss her complaint and deny leave further to amend (she already had one opportunity to amend).  This Kentucky plaintiff may be singing the blues (or at least bluegrass), but this seems like the correct result. 

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When it comes to legal developments in the nation to our north, we are happy to defer to actual Canadian lawyers. Here, we present a guest post from Ashley Paterson and Gina Azer of Bennett Jones. This is Ashley’s second guest post, which means she is close to qualifying for the coveted FOB (friend of the Blog) designation. As always, our guest posters are 100% responsible for their content, and thus entitled to 100% of the credit or blame, as it may be. 

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The talc saga continues in the Great White North. A Canadian court (in British Columbia) accepted a plaintiff’s second attempt to show a workable causal link methodology between talc powder and ovarian cancer and certified a national class action in Ennis v. Johnson & Johnson, 2024 BCSC 1759.

For those unfamiliar with the Canadian class action regime, like in the U.S., proposed class actions must be certified in order to proceed. In British Columbia, the test for certification is as follows (and is relatively similar throughout Canada):

the court must certify a proceeding as a class proceeding if all of the following requirements are met:

a. the pleading discloses a cause of action;

b. there is an identifiable class of two or more persons;

c. the claims of the class members raise common issues, whether or not those common issues predominate over issues affecting only individual members;

d. a class proceeding would be the preferable procedure for the fair and efficient resolution of the common issues; and

e. there is a representative plaintiff who: (i) would fairly and adequately represent the interests of the class; (ii) has produced a plan for the proceeding that sets out a workable method of advancing the proceeding on behalf of the class and of notifying class members of the proceeding; and (iii) does not have, on the common issues, an interest that is in conflict with the interests of other class members.

First, a little background on the Ennis v. Johnson & Johnson action. The plaintiff first moved unsuccessfully to have the class action certified in February 2020. In November 2020, the British Columbia court released its decision [2020 BCSC 1746] refusing to certify the action due to insufficiency of the evidence linking the use of talc powder to ovarian cancer. The plaintiff had attempted to link talc powder use to all ovarian cancers. In their response, the defendants opposed certification in part on the basis that there was insufficient evidence of a common biological or causal mechanism for either epithelial or non-epithelial ovarian cancers. Though this point could have been fatal to the plaintiff’s certification application at the time, the court granted leave to the plaintiff to obtain more evidence and redefine the class definition accordingly.

With leave, the plaintiff returned to court years later with more evidence and an amended claim. In the plaintiff’s amended claim, the putative class was narrowed to all Canadian persons (excluding Quebec) that used talc powder and subsequently developed epithelial ovarian cancer. The amendment meant that the evidence at the return of the certification application would need to show a basis in fact for a causal link between exposure to talc powder and epithelial ovarian cancer. The court held that the plaintiff’s reliance on the new evidence of Dr. Cramer, an epidemiologist and gynecologist from Harvard (see here for where he got knocked out in similar U.S. litigation), was sufficient to bring them across the certification line. Of course, the merit of the evidence itself is not tested at the certification stage. And here, it was enough to meet, in the court’s words, “the very low bar of demonstrating a methodology that suggests Baby Powder is a contributing cause to the development of epithelial ovarian cancer in some individuals.”

In response to the evidence of Dr. Cramer, the defendants pointed to the evidence of their expert which indicated that five different types of epithelial ovarian cancers were at issue, all with different causal mechanisms, some of which are independent of talc powder. The defendants also argued that Dr. Cramer’s proposed methodology would not advance the class members’ claims since individual issues, such as personal histories, circumstances, histological factors, and characteristics would dominate resolution of the common issues. But the court refused to weigh the conflicting expert evidence at the certification stage and instructed the plaintiff to rephrase the common question to exclude epithelial ovarian cancers that are not linked to talc. As a result, putative class members will be required to determine whether they were diagnosed with a non-talc related epithelial ovarian cancer in order to know whether they are class members.

The defense further challenged Dr. Cramer’s methodology by noting that it failed to provide “some evidence” (another way of saying “some basis in fact,” the evidentiary standard for the certification criteria other than a pleaded cause of action) of a causal link between talc and any epithelial ovarian cancer and failed to conclude that one biological methodology can be linked to all types of epithelial cancers. The defendants highlighted that Dr. Cramer’s methodology failed to use the benchmark odds ratio of 2.0 to show the alleged causal link. Dr. Cramer acknowledged this deficiency and admitted to formulating his own odds ratio after accounting for a wide range of individual factors in his research study subjects. The defendants responded that a methodology reliant on individual assessments at each instance could not be applicable to the entire class. However, notwithstanding Dr. Cramer’s 1.29 odds ratio and his consideration of a multitude of individual factors, the court accepted his methodology because, in theory, it could establish a reliable measure of the general association between the use of talc powder and epithelial ovarian cancers. In other words, the combination of the odds ratio with other factors was enough to meet the standard for a workable methodology for class certification purposes.

With respect to the fourth branch of the certification test, whether a class proceeding is the preferable procedure to advance the action, the defendants argued that individual class members would need to show how the risk materialized in the context of their specific cancer, and that Dr. Cramer himself gave evidence that he would need to consider each individual class member’s medical history to show specific causation. Despite this, the court held that Dr. Cramer’s evidence showed the required general causal relationship and answering the question of whether talc powder causes epithelial ovarian cancer would advance the claims of all class members, whether affirmatively or negatively.

A significant moving piece in the background of all this was that unlike the FDA, Health Canada published its screening assessment of talc under the Chemicals Management Plan, finding that the latest scientific evidence supports that “inhaling loose talc powders and using certain products containing talc in the female genital area may be harmful to human health.”

To conclude, certification of this case (in particular, on the second try) reinforces the need for plaintiffs to show a plausible and credible methodology for establishing general causation on a class-wide basis. In this case, evidence of such a methodology was apparently enough to outweigh the clear evidence (from the plaintiff’s expert!) that individualized assessments would be required. The decision also reinforces the challenges faced by defendants in responding to such evidence without creating the dreaded “battle of the experts” that often leads Canadian courts to certify cases since conflicting expert evidence is not to be addressed at the certification stage.

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United States v. Cal. STEM Cell Treatment Cntr., Inc., 2024 U.S. App. LEXIS 24525 (9th Cir. 2024), is not, strictly speaking, a product liability case at all.  But it hits several of our personal sweet spots.  For example, it is from the Ninth Circuit, where we clerked for Judge Norris.  It involves another of our old employers, the United States Attorney’s Office in the Central District of California.  So the Cal. STEM case takes us on a trip down memory lane.  Further, the case turns on FDA enforcement of its regulations and whether the product at issue constitutes a drug.  We occasionally bump into that issue in our current work for paying clients.  The cherry on top is that the official opinion of the Ninth Circuit breaks down into different portions authored by different judges.  Plus, there are a lot of weird acronyms.  What’s not to love about this case?

The defendant in the case purported to treat folks with a stem cell slurry mixture called stromal vascular fraction (SVF). SVF is a liquefied mixture of cells and cell debris derived from fat tissue. Under a microscope, it looks a bit like honeycomb. But that is where the resemblance ends.  SVF does not seem in the least bit sweet or yummy. The SVF was created by extracting (via liposuction) fat tissue from a patient and breaking it down (centrifuge, etc.) to concentrate the portion containing stem cells. The resulting SVF was then administered to the patient.  For example, the defendant injected SVF directly into a patient’s knee to treat osteoarthritis.  This sort of procedure goes by the rubric of regenerative medicine. As you might imagine, such treatment is hardly free from controversy with respect to safety and efficacy.

The FDA filed a civil lawsuit against the defendant, alleging that the defendant’s SVF treatments were human cells, tissues, and cellular based products (HCT/Ps).  Such products, according to the FDA, constituted drugs that had not been approved, were improperly manufactured, and were inadequately labeled.  The FDA sought injunctive relief. The same buzzwords that plaintiffs in product liability cases now seem to find irresistible — adulteration and misbranding — reared their ugly heads in the Cal. STEM case.  After a bench trial, the district judge found for the defendant, concluding that the SVF treatments were not drugs and, even if they were, the “same surgical procedure” (SSP) regulatory exception applied because the defendant removed HCT/Ps from a patient and then implants them into the same patient during the same surgical procedure. That was a dream result for the defendant.   

But the Ninth Circuit is where defendant dreams go to die, and that is what happened here. The appellate court held that under the plain words of the regulations, the SVF treatment was a drug. The definition of “drugs” is quite broad: “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” The defendant did not really dispute that a literal reading of such broad language put them in the soup (or slurry?), but argued that such breadth could lead to absurd results. That may be so, said the Ninth Circuit, but there are plenty of cases applying the broad definition of “drugs,” and there was nothing particularly absurd about including SVF treatments as drugs.  Even if SVF was a biologic, a product can be both a drug and a biologic under the regulation. 

In a last effort to fend off the FDA’s interpretation of SVF as a drug, the defendant invoked the major questions doctrine, which, when applicable, requires an agency to point to clear congressional authorization for the power claimed by the agency.  But the Ninth Circuit held that the major question doctrine was inapplicable here, because this case did not present a matter of extreme economic and political significance, nor did it represent a sudden assertion or transformative expansion of agency authority.  In any event, some recent legislation suggests that Congress does, indeed, presuppose that FDA regulates stem cell therapies.

The Ninth Circuit held that the SSP exception did not apply because the removed HCT/P is the fat tissue, not the cells implanted for implantation.  They are not “the same.” There was a lot of processing in between the extraction and the injection. The fat tissue was significantly altered. Believe it or not, the court’s interpretation of sameness – or in this case, not sameness – revolves around the word “such.”  The regulation’s exception includes the word “such” when discussing the same surgery scenario.  Looking to Black’s Law Dictionary, the court reasoned that “such” refers back to something already mentioned – an antecedent.  What was removed was fat tissue.  What was later injected was something different.  The court concluded that “a surgical procedure cannot qualify for the SSP exception if it involves more than minimal manipulation of HCT/Ps.” Such was the case here. Goodbye exception.

The judge who wrote the court’s opinion holding that SVF was a drug wrote a concurrence, on different grounds, as to why the SSP exception did not apply.  After examining the text, structure, purpose, and history of the regulation, she would hold that the SSP exception was ambiguous.  Faced with such ambiguity, the court owed Auer deference to the FDA’s reasonable interpretation of the SSP exception as not applying to the defendant’s treatments.  (For those of you who have imperfect recollection of your old Administrative Law class, Auer deference applies when an agency interprets its regulations, whereas the recently overruled Chevron deference applied when an agency interpreted statutes.) 

The case was reversed and remanded for further proceedings.